Subacute thyroiditis and COVID-19 vaccines: a case/non-case study.
PURPOSE: Some case reports have suggested a possible association between COVID-19 vaccines and subacute thyroiditis (SAT), however, to our knowledge, no study has analyzed this possible relationship. This study aimed to analyze whether a disproportionate number of cases of SAT were reported in the EudraVigilance database for four COVID-19 vaccines (BNT162b2, mRNA-1273 ChAdOx1-S or Ad26.COV2.S).
METHODS: A case/non-case study was conducted to assess the association between SAT and COVID-19 vaccines, calculating the reporting odds ratios (RORs) up to December 2, 2021. Cases were selected using the preferred term 'subacute thyroiditis'. First, cases involving COVID-19 vaccines were compared with those involving all other drugs. Secondly, the RORs for COVID-19 vaccines compared with other viral vaccines (overall and influenza vaccines only) were obtained.
RESULTS: Until December 2, 2021, of 1,221,582 spontaneous cases of adverse reactions with the four vaccines, we found 162 SAT cases: BNT162b2 (n = 103), mRNA-1273 (n = 27), ChAdOx1-S (n = 31) and Ad26.COV2.S (n = 1). SAT cases were found to be reported more frequently in association with BNT162b2, mRNA-1273, and ChAdOx1-S vaccines than with other drugs. Moreover, we found a signal of disproportionate reporting for SAT with BNT162b2 and mRNA-1273 vaccines comparing with other viral vaccines (BNT162b2 ROR 3.58, 95% CI 1.92-6.66; mRNA-1273 ROR 3.44, 95% CI 1.71-6.94). However, this association was absent when these COVID-19 vaccines were compared with influenza vaccines.
CONCLUSIONS: In EudraVigilance, SAT is relatively more frequently reported in association with mRNA COVID-19 vaccines than with other viral vaccines. Well designed observational studies are needed to confirm these results.
|投稿者||Garcia, Montserrat; Albizua-Madariaga, Itziar; Lertxundi, Unax; Aguirre, Carmelo|
|組織名||Osakidetza Basque Health Service, Galdakao-Usansolo Hospital, Basque Country;Pharmacovigilance Unit, Biocruces Bizkaia Health Research Institute, Barrio;Labeaga 46 A, Galdakao, 48960, Spain. firstname.lastname@example.org.;Pharmacovigilance Unit, Galdakao, Bizkaia, Spain.;Bioaraba Health Research Institute, Osakidetza Basque Health Service, Araba;Mental Health Network, Araba Psychiatric Hospital, Pharmacy Service, Gasteiz,;Alava, Spain.;Labeaga 46 A, Galdakao, 48960, Spain.;Department of Pharmacology, Faculty of Medicine and Nursing, University of the;Basque Country, Leioa, Spain.|